SYNETEC

Computer, Diagnostic, Programmable

ELA MEDICAL, INC.

The following data is part of a premarket notification filed by Ela Medical, Inc. with the FDA for Synetec.

Pre-market Notification Details

• Device ID: K002817
• 510k Number: K002817
• Device Name: SYNETEC
• Classification: Computer, Diagnostic, Programmable
• Applicant: ELA MEDICAL, INC. 2950 XENIUM LN. NORTH, #120 Plymouth, MN 55441
• Contact: Susan Olive
• Correspondent: Susan Olive; ELA MEDICAL, INC. 2950 XENIUM LN. NORTH, #120 Plymouth, MN 55441
• Product Code: DQK
• CFR Regulation Number: 870.1425 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2000-09-11
• Decision Date: 2001-05-02